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Clinical Trials in the USA / NCT03404778
Enrolling by invitation Observational

Comprehensive Reverse Shoulder Data Collection

NCT03404778 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Observational
Started
2010-03-07
Last updated
2025-10-30

Condition(s) studied

Arthropathy of Shoulder RegionGrossly Deficient Rotator CuffOsteoarthritis of the ShoulderRheumatoid Arthritis Without Humeral Metaphyseal DefectsPost-Traumatic Arthitis

Investigational drug(s) / intervention(s)

Biomet Comprehensive Reverse Shoulder

Biomet Comprehensive Reverse Shoulder: Designed to eliminate the potential for scapular notching, this reverse shoulder system combines a a true locking mechanism that minimized wear and oxidative breakdown with a modular central screw for secure fixation.

Study summary

This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Biomet® Comprehensive™ Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. * The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. * The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Exclusion Criteria: * Absolute contraindications include infection, sepsis, and osteomyelitis. * Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. * Osteoporosis. * Metabolic disorders which may impair bone formation. * Osteomalacia. * Distant foci of infections which may spread to the implant site. * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Primary outcome measure(s)

  • Pain Score — 1 year
    Pain Score is assessed for each subject by asking them to indicate their current level of pain based on a 5 level scale, with "None" as the best outcome and "Severe" as the worst. Improvement of pain score at one year from pre-operative levels will be assessed.

Trial sites (4)

FacilityCityRegionStatus
Acromion LLC Towson Maryland
William Beaumont Hospital Royal Oak Michigan
Allina Health System DBA Sports and Orthopaedic Specialists Edina Minnesota
Joint Implant Surgeons New Albany Ohio

More Zimmer Biomet trials in the USA

MDR ExploR Radial Head System PMCF Enrolling by invitation
Clinical Outcomes Study of the Nexel Total Elbow Recruiting
MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head Enrolling by invitation
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System Active, not recruiting
Embody Post-Market Clinical Follow-Up Study Active, not recruiting

Other trials for the same condition

Pyrocarbon Clinical Follow-up Study Active, not recruiting
Database Retrieval for the Comprehensive Shoulder Active, not recruiting
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03404778 on ClinicalTrials.gov ↗ ← All trials in the USA